Identity
- Trade Name
- Lexie B2, Powered by Bose FDA UDI
- Generic Name
- Air-conduction hearing aid, receiver-in-canal FDA UDI
- Device Name
- Lexie B2, Powered by Bose re-chargeable self-fitting hearing aid FDA UDI
- Model / Reference
- LB2001 FDA UDI
- Description
- Lexie B2, Powered by Bose re-chargeable self-fitting hearing aid FDA UDI
Identifiers
- Catalog Number
- LBO00001B2 FDA UDI
- Primary DI / UDI-DI
- 00850022464638 FDA UDI
- 510(k) Number
- K211008 FDA UDI
- FDA Product Code
- QDD FDA UDI
- GMDN Term
- Air-conduction hearing aid, receiver-in-canal FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3325 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Lexie B2, Powered by Bose by Hearx Group (pty) Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Hearx Group (pty) Ltd
Sources (1)
- FDA UDI db6aeb77-43ee-4acd-8373-35908b6beee8 38 fields · synced May 30, 2026